Health Canada has indicated that it will permit the claim
"Product X is authorized for sale by Health Canada" in
advertising of an authorized health product bearing a Drug
Identification Number (DIN), Homeopathic Medicine Number (DIN-HM)
or Natural Product Number (NPN).
Previously, Health Canada took the position that such a claim
was not permitted on the basis of Section C.01.007 of the Food
and Drug Regulations, and Section 92 of the Natural Health
Products Regulations. These sections prohibit making any
reference to the Food and Drugs Act or the foregoing
regulations on the label of, or in any advertisement for, a drug
unless such reference is a legislatively prescribed
requirement. Health Canada's previous position on the
application of these sections is articulated in Section 2.10 of
Health Canada's Consumer Advertising Guidelines for
Marketed Health Products, which states that "claims that
state or imply product endorsement or authorization by Health
Canada or any other government agency are prohibited". Part of
the rationale behind Health Canada's previous position
was that the use of a DIN, DIN-HM or NPN is a sufficient indicator
that a product had been authorized by Health Canada.
Health Canada's new stance appears to be in response to
requests from manufacturers to be able to clearly communicate to
Canadian consumers the distinction between their authorized drug
products and unauthorized third party products. It is anticipated
that Health Canada will update its Consumer Advertising
Guidelines for Marketed Health Products and any other
materials that reference its previous position on this point during
the next round of revisions.
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